上海交通大学学报(医学版) ›› 2019, Vol. 39 ›› Issue (7): 789-.doi: 10.3969/j.issn.1674-8115.2019.07.018

• 短篇论著 • 上一篇    下一篇

注册于中国临床试验注册中心的放射治疗临床试验特征分析

张欣,黄锣,陶丹,李丛,谢林,王雨晴,龙斌   

  1. 重庆大学附属肿瘤医院 /重庆市肿瘤医院 /重庆市肿瘤研究所肿瘤放射治疗中心,重庆 400030
  • 出版日期:2019-07-28 发布日期:2019-08-26
  • 通讯作者: 龙斌,电子信箱:870759354@qq.com。
  • 作者简介:张欣(1988—),女,主治医师,博士;电子信箱: zhangxin9964@126.com。
  • 基金资助:
    重庆市科研院所绩效激励引导专项(cstc2017jxjl130016);重庆市基础研究与前沿探索项目(cstc2018jcyjAX0806)

Characteristics of radiotherapy trials registered in Chinese Clinical Trial Registry (ChiCTR)

ZHANG Xin, HUANG Luo, TAO Dan, LI Cong, XIE Lin, WANG Yu-qing, LONG Bin   

  1. Tumor Radiotherapy Center, Chongqing University Cancer Hospital/Chongqing/Cancer Hospital/Chongqing Cancer Institute, Chongqing 400030, China
  • Online:2019-07-28 Published:2019-08-26
  • Supported by:
    Performance Incentive and Guidance Program of Chongqing Scientific Research Institutions, cstc2017jxjl130016; Basic Research and Frontier Exploration Projects in Chongqing, cstc2018jcyjAX0806

摘要: 目的 ·分析注册于中国临床试验注册中心( ChiCTR)的放射治疗(放疗)临床试验的特征。方法 ·检索自 ChiCTR成立至 2018年 12月 1日的放疗临床试验,记录并分析特征。结果 · ChiCTR累计注册放疗临床试验 274项,项目数逐年上升。其中 79.9%为预注册, 51.5%的征募状态为正在进行, 27.4%有数据管理委员会。肺癌、鼻咽癌、肝癌、食管癌为前 4位研究癌种。 53.7%开展于北京、上海、广东和四川。 86.4%为单中心研究。 69.7%的经费来源为个人或单位自筹。 40.5%着力于初期探索新的放疗方案。研究类型主要为干预性研究( 50.7%)和观察性研究( 39.8%)。企业资助的项目更倾向于较大样本量和采用随机化分组,自筹项目更倾向于采用盲法(均 P<0.05)。结论 ·中国放疗临床试验整体较为规范,但地域分布不均衡,研究规模偏小,存在注册信息填写错误及不全的情况。

关键词: 放射治疗, 临床试验, 特征

Abstract: Objective · To analyze the characteristics of radiotherapy clinical trials registered in Chinese Clinical Trials Registry (ChiCTR). Methods · The radiotherapy clinical trials registered in ChiCTR before December 1, 2018 were retrieved. Their characteristics were recorded and analyzed. Results · A total of 274 registered radiotherapy clinical trials were in ChiCTR, and the number increasedyear, in which 79.9% were preregistered, 51.5% were ongoing, and 27.4% had data monitoring committees. The top four researched diseases were lung cancer, nasopharyngeal cancer, liver cancer and esophageal cancer. 53.7% were conducted in Beijing, Shanghai, Guangdong and Sichuan. 86.4% were single-center. 69.7% were fundedindividuals or units. 40.5% focused on new radiotherapy schemes. The main types of research were intervention study (50.7%) and observational study (39.8%). Enterprise-funded projects tended to larger sample size and randomization, while self-funded projects tended to blinding (all P<0.05). Conclusion · Radiotherapy clinical trials in China are relatively standardized, but the regional distribution is unbalanced, the scale of research is small, and some registration information is incorrect or incomplete.

Key words: radiotherapy, clinical trials, characteristics

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